Uceris

Product NDC: 68012-309
11-digit product format: 680120309
Labeler code: 68012
Product ID: 68012-309_250346dc-e6de-b148-e063-6394a90a1ca3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: budesonide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Santarus Inc.
Application: NDA203634
Marketing category: NDA
Marketing start: 2013-01-14
Substance: BUDESONIDE
Active strength: 9 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203634-001	UCERIS	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N203634-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203634-001	10307375	2031-09-07		Drug product	2019-06-14
N203634-001	10660858	2031-09-07		Drug product	2020-07-21
N203634-001	8895064	2031-09-07		Drug product	2014-11-25
N203634-001	9132093	2031-09-07		Drug product	2015-09-16
N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N203634-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203634-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203634-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203634-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203634-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203634-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203634-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203634-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203634-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203634-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203634-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203634-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203634-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203634-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203634-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203634-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203634-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203634-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203634-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203634-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203634-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203634-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203634-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203634-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203634-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203634-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203634-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203634-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203634-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203634-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203634-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203634-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203634-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203634-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203634-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203634-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203634-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203634-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203634-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203634-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Uceris
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	9 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1366550	Internal RxNorm lookup
1366556	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92cbb190-8851-46ed-bfe0-166ca62ef2e9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7816cdf6-b925-4282-bedd-11ae25d518a1	Product name	1	20250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d	Product name	2	20240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
218c043e-94e5-4e66-a363-d0d446485bc6	Product name	2	20210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7	Product name	9	20210127
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68012-309-01	2024-01-30	C162847	48780-1	1030e364-fc64-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use UCERIS safely and effectively. See full prescribing information for UCERIS. UCERIS ® (budesonide) extended-release tablets, for oral use Initial U.S. Approval: 1997
68012-309-02	2024-01-30	C162847	48780-1	1030e364-fc64-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use UCERIS safely and effectively. See full prescribing information for UCERIS. UCERIS ® (budesonide) extended-release tablets, for oral use Initial U.S. Approval: 1997
68012-309-30	2024-01-30	C162847	48780-1	1030e364-fc64-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use UCERIS safely and effectively. See full prescribing information for UCERIS. UCERIS ® (budesonide) extended-release tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68012-309-01	Uceris	2 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	2	20
68012-309-02	Uceris	2 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	2	20
68012-309-30	Uceris	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68012-309-30	EA - Each	68012-309	68850977-ac76-4286-b550-ab12cd4ac6a0	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68012-309	UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS INC.]	20	Current NDC, Legacy NDC, 3 package rows	20241023_92cbb190-8851-46ed-bfe0-166ca62ef2e9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
budesonide	BUDESONIDE	Oceanside Pharmaceuticals	a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203634 application number: NDA203634
Uceris	BUDESONIDE	Santarus Inc.	92cbb190-8851-46ed-bfe0-166ca62ef2e9	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203634 application number: NDA203634 ndc (product): 68012-309

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1366550	budesonide 9 MG 24HR Extended Release Oral Tablet	PSN	92cbb190-8851-46ed-bfe0-166ca62ef2e9	20
1366556	Uceris 9 MG 24HR Extended Release Oral Tablet	PSN	92cbb190-8851-46ed-bfe0-166ca62ef2e9	20
1366556	24 HR budesonide 9 MG Extended Release Oral Tablet [Uceris]	SBD	92cbb190-8851-46ed-bfe0-166ca62ef2e9	20
1366550	24 HR budesonide 9 MG Extended Release Oral Tablet	SCD	92cbb190-8851-46ed-bfe0-166ca62ef2e9	20
1366556	24 HR Uceris 9 MG Extended Release Oral Tablet	SY	92cbb190-8851-46ed-bfe0-166ca62ef2e9	20
1366550	budesonide 9 MG 24 HR Extended Release Oral Tablet	SY	92cbb190-8851-46ed-bfe0-166ca62ef2e9	20
1366556	Uceris 9 MG 24 HR Extended Release Oral Tablet	SY	92cbb190-8851-46ed-bfe0-166ca62ef2e9	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68012-309-01	68012030901	2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)	2013-01-14	0000-00-00	No	No	Current
68012-309-02	68012030902	2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02)	2013-01-14	0000-00-00	No	No	Current
68012-309-30	68012030930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68012-309-30)	2013-01-14	0000-00-00	No	No	Current